MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2004-05-27 for MDA ANTITHROMBIN III * 252574 manufactured by Biomerieux, Inc..
[364338]
Customer called to ask about results given with the mda antithrombin iii reagent (mda atiii). The customer reported that they had questionably low results. The customer was advised to run with the caps off rather than in cap piercing mode. The results were higher and closer to expected values. The customer faxed in the data which showed a marked difference in results between "caps on" and "caps off. " the customer reported that two pts were placed on coumadin based on the results with the caps on.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2004-00006 |
| MDR Report Key | 527411 |
| Report Source | 05 |
| Date Received | 2004-05-27 |
| Date of Report | 2004-05-21 |
| Date of Event | 2004-04-23 |
| Date Mfgr Received | 2004-04-23 |
| Date Added to Maude | 2004-06-02 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JOCELYN JENNINGS |
| Manufacturer Street | 100 RODOLPHE ST |
| Manufacturer City | DURHAM NC 27712 |
| Manufacturer Country | US |
| Manufacturer Postal | 27712 |
| Manufacturer Phone | 9196202968 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MDA ANTITHROMBIN III |
| Generic Name | CLASS II, 864.7060 ANTITHROMBIN III ASSAY |
| Product Code | JPE |
| Date Received | 2004-05-27 |
| Model Number | * |
| Catalog Number | 252574 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 516579 |
| Manufacturer | BIOMERIEUX, INC. |
| Manufacturer Address | * DURHAM NC * US |
| Baseline Brand Name | MDA ANTITHROMBIN III |
| Baseline Generic Name | CLASS II, 864.760 ANTITHROMBIN III ASSAY |
| Baseline Model No | * |
| Baseline Catalog No | 252574 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2004-05-27 |